Joshua Cohen

Human immunodeficiency virus (HIV) remains a substantial public health challenge in the United States (US). As of 2023, an estimated 1.13 million people aged 13 years or older were living with HIV ...

Objective: To assess adherence and persistence with first-line single-tablet regimen (STR) and multi-tablet regimen (MTR) antiretroviral therapy (ART) in newly treated HIV-1 patients. Methods: Retrospective analysis of longitudinal pharmacy claims among US patients initiating ART between 1/1/2016 and 5/31/2016 (index date was defined by first ART claim for STRs, and fill date for the last therapy in the regimen for MTRs). Adherence was assessed over a 12-month period and reported as the proportion of adherent or non-adherent (defined as ≤5-day and > a 5-day gap between successive fills, respectively) patients. Sensitivity analysis using ≤7-day and ≤14-day gap thresholds to define adherence was performed. Persistence was assessed as the number of days on therapy from index until treatment discontinuation (>90 day gap in therapy). Kaplan–Meier curves and Cox Proportional Hazard models were generated to evaluate discontinuation rates. Assessments were performed on STRs vs MTRs overall and by regimen. Results: Patients initiating ART (STR: n=10,623; MTR: n=2504) had a mean age of 42.8 years; 76.0% were male. STR patients were >2 times more likely to be adherent over 12 months than MTR patients (24.9% vs 11.7%, respectively). Patients using EVG/COBI/FTC/TAF had greater adherence than those using other STRs. Among MTRs, patients were more adherent with FTC/TDF+DTG (15.1%) than other MTRs. Persistence was also greater with STRs, with MTR patients being 61% more likely to discontinue therapy. Persistence was best for FTC/TAF-based regimens. Predictors of treatment discontinuation included younger age, female gender, and Medicare or Medicaid insurance type. Conclusion: Patients receiving STRs were significantly less likely to discontinue therapy and were more adherent with their regimens, providing further evidence of greater adherence and persistence with STRs versus MTRs. However, there was a large proportion of patients who interrupted or discontinued treatment. Further research examining treatment patterns beyond first line is warranted.

Pre-exposure prophylaxis (PrEP) effectively reduces human immunodeficiency virus (HIV) transmission. We aimed to estimate the impact of different PrEP prioritization strategies among Black and Latino men who have sex with men (MSM) in the United States, populations most disproportionately affected by HIV. We developed an agent-based simulation to model the HIV epidemic among MSM. Individuals were assigned an HIV incidence risk index (HIRI-MSM) based on their sexual behavior. Prioritization strategies included PrEP use for individuals with HIRI-MSM ≥10 among all MSM, all Black MSM, young (≤25 years) Black MSM, Latino MSM, and young Latino MSM. We estimated the number needed to treat (NNT) to prevent one HIV infection, reductions in prevalence and incidence, and subsequent infections in non-PrEP users avoided under these strategies over 5 years (2016–2020). Young Black MSM eligible for PrEP had the lowest NNT (NNT = 10) followed by all Black MSM (NNT = 33) and young Latino MSM (NNT = 35). All Latino MSM and all MSM had NNT values of 63 and 70, respectively. Secondary infection reduction with PrEP was the highest among young Latino MSM (53.2%) followed by young Black MSM (37.8%). Targeting all MSM had the greatest reduction in prevalence (14.7% versus 2.9%–3.9% in other strategies) and incidence (49.4% versus 9.4%–13.9% in other groups). Using data representative of the United States MSM population, we found that a strategy of universal PrEP use by MSM was most effective in reducing HIV prevalence and incidence of MSM. Targeted use of PrEP by Black and Latino MSM, however, especially those ≤25 years, had the greatest impact on HIV prevention.

Objective: We examine whether drugs’ excluded versus recommended status on pharmacy benefit manager exclusion lists corresponds to evidence from cost‐effectiveness analyses, lack of evidence, or rebates.Data Sources: To find cost‐effectiveness data for drugs on 2016 exclusion lists of CVS Caremark and Express Scripts, we searched the Tufts Cost‐Effectiveness Analysis Registry and the peer‐reviewed literature.Study Design: For each excluded and recommended drug, we compared the mean cost‐per‐QALY, and we calculated the difference between the numbers of excluded and recommended drugs for which we could find no cost‐effectiveness evidence.Data Collection: As keywords in our searches, we used the brand and generic drug name and “cost‐effectiveness” and “cost‐per‐quality‐adjusted life‐year.” Of 240 retrieved studies, 110 were selected for analysis.Principal Findings: The mean cost‐per‐QALY for excluded drugs was higher ($51,611) than the cost‐per‐QALY for recommended drugs ($49,474), but not statistically significant. We could find no cost‐effectiveness evidence in the Registry or peer‐reviewed literature for 23 of the excluded drugs, and no evidence for 5 of the recommended drugs.Conclusions: Cost‐effectiveness does not correlate with a drug's excluded or recommended status. Lack of cost‐effectiveness evidence favors a drug's excluded status.